A Clinical Study of IBI130 for Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase 1/2, Multicenter, Open-label Study of IBI130 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923008
• Other study ID #: CIBI130A101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 14, 2023
• Est. completion date: October 31, 2026

Study information

• Verified date: November 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: Serena Dong
• Phone: 0512 69566088
• Email: suhua.dong[@]innoventbio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 1/2 multicenter, open-label, first-in-human study of IBI130. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI130, plan to enroll 20~182 subjects,and a phase 2 to explore efficacy, safety and tolerability of IBI130 at RP2D in specified types of solid tumor.Approximately 150 evaluable subjects will be enrolled for phase 2.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: October 31, 2026
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;

2. Male or female subjects = 18 years old;

3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;

4. Anticipated life expectancy of = 12 weeks;

5. Adequate bone marrow and organ function

Exclusion Criteria:

1. Enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study;

2. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter;

3. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;

4. Received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• IBI130
Subjects will receive IBI130 until unacceptable toxicity, disease progression, withdrawal of consent, occurrence of other reasons for discontinuing study therapy, or for a maximum of 24 months of treatment, whichever occurs first.

Locations

Country	Name	City	State
Australia	Sunshine Coast University	Birtinya	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs)	Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0	Up to 30 days post last dose
Secondary	objective response rate (ORR)	ORR is the percentage of complete response(CR) plus partial response assessed(PR) per RECIST v1.1 criteria	Time from first dose to best response to treatment, assessed up to 3 years
Secondary	duration of response(DoR)	For subjects with CR or PR,duration of response(DoR) is the time from the first documented CR or PR to disease progression assessed per RESICT v1.1 criteria or death	Duration of response from the first documentation of objective response (confirmed CR or PR) to the first documented disease progression, assessed up to 3 years
Secondary	overall survival (OS)	Time from the date of the first dose to death of the subject due to any cause	Time from first dose to death, assessed up to 3 years